FDA Label for Dolodent Maximum Strength
View Indications, Usage & Precautions
Dolodent Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Pharmadel Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient And Purpose
.
Otc - Purpose
Active ingredient Purpose
Benzocaine 20%..............................Oral pain reliever
Uses
For the temporary relief of
- canker sores
- minor injury of the mouth and gums
- minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Warnings
Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics.
Flammable. Keep away from fire or flame. Avoid smoking during application.
Do Not Use
- more than directed
- for more than 7 days unless directed by a dentist or doctor
- for teething
- in children under 2 years of age
Stop Use And Ask Your Doctor Or Dentist If
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
Keep Out Of Reach Of Children.
If more than used for pain is accidentally swallowed or an allergic reaction occurs, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 2 years of age and older:
- apply product to a cotton swab or finger to the affected area. Allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor
- children under 12 years of age a should be supervised in the use of the product
- children under 2 years of age: do not use
Other Information
- do not use if clear seal over cap is torn, broken, or missing
- store between 68-77°F (20-25°C)
Inactive Ingredients
alcohol, clove oil, glycerin, polyethylene glycol, propylene glycol, sodium saccharin, sodium methylparaben
Questions Or Comments?
+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
Dist. By/ Por:
Dist. by/ por:
PHARMADEL LLC
New Castle, DE 19720
+1-866-359-3478
www.pharmadel.com
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